Activator for Autoinjector

ABSTRACT

The invention relates to an activator unit for an autoinjector, comprising a substantially cylindrical housing ( 3 ) in which an axially movable pressure pin ( 4 ) is guided, said pressure pin being insertable counter to a spring unit and being lockable, when inserted, by means of detent projections ( 6 ) of a retaining element ( 5 ) that is connected to the pressure pin. The spring unit comprises a first coil spring ( 1 ) and at least one second coil spring ( 2 ) having a larger diameter than the first coil spring, the second coil spring being coaxial to the first coil spring.

The invention relates to an activator unit for an autoinjector,comprising a substantially cylindrical housing in which an axiallymovable pressure pin is guided, said pressure pin being insertablecounter to a spring unit and being lockable, when inserted, by means ofdetent projections of a retaining element that is connected to thepressure pin. The invention also relates to an autoinjector comprisingthe activator unit.

Activators of the type mentioned at the outset are used as components ofmedical hypodermic syringes that can be operated simply, automatically,and mostly for one-time use. Such a syringe, called an autoinjector, isplaced with its distal end on a region of interest of the body of ahuman and is then triggered by a simple manual action, often in theproximal region of the autoinjector. The terms “proximal” and “distal”refer to the perspective of the person using an autoinjector.

WO 2005/021070 A1 shows a device for automatic injection of injectionfluids. Said device also comprises an activator in a cylindrical housingin which a piston rod can be pushed by means of a spring. When thespring is triggered, subsequently pushing the piston rod out towards thedistal end of the activator, a cartridge is connected to an injectionneedle, the needle is pushed out of the device for automatic injection,and the piston rod is pressed into the cartridge such that a liquid drugis injected through the needle. Optionally, the needle may already beconnected to the cartridge. The disadvantage of this teaching is thatthe energy accumulator of the activator consists of a coil spring. As aresult, the force that is required to inject the liquid can be appliedonly at the end of the automatic injection process, that is, when thecoil spring is in a nearly relaxed state. The available force issufficient to press a liquid drug through the cannula. However, it is nolonger sufficient to press a viscous drug through the cannula and/or topress the drug through a cannula that has a smaller diameter.

It is the object of the invention to provide an activator as mentionedat the outset which applies greater force when the drug is to beinjected. In addition, the activator should not be considerably morecomplex or costly to produce than prior art activators; it should alsobe easy and safe to operate as compared with prior art activators andshould not have larger outer dimensions. A further object is to makeoperating an autoinjector more comfortable for the patient.

The activator according to the invention attains this object in that thespring unit comprises a first coil spring and at least one second coilspring having a larger diameter than the first coil spring, the secondcoil spring being coaxial to the first coil spring. A piston rod thatextends from the piston to the proximal end of the activator is nolonger provided.

A preferred embodiment of the activator unit is characterized in thatthe first coil spring and the second coil spring have substantially thesame length.

In one embodiment of the invention, the first coil spring and the secondcoil spring are designed as parts of an integral double spring.

In a further embodiment of the invention, the second coil spring isretained and locked by an element that can be moved by the first coilspring, wherein the locking of the second coil spring can be unlockedwhen the first coil spring is at an outer release point.

In another embodiment of the invention, the first coil spring isretained and locked by an element that can be moved by the second coilspring, wherein the locking of the first coil spring can be unlockedwhen the second coil spring is at an outer release point.

In one embodiment of the invention, the activator unit preferablycomprises an activator sleeve that can be moved in an axial direction,by which the detent projections can be displaced such that the lock isunlocked and the pressure pin can be moved by the spring unit.

It is further preferred in the embodiment of the device according to theinvention that the activator unit comprises a removable safety cap whichincludes an element that fixes the detent projections in place.

In one embodiment of the invention, the activator unit comprises at itsdistal end a thread or a bayonet lock by which it can be connected to aninjector unit.

In one embodiment of the invention, the pressure pin preferably has onits distal end face mechanical means for breaking a seal.

The invention also relates to an autoinjector that includes an activatorunit according to the invention.

In the following, the invention will be explained in more detail withreference to an embodiment shown in the figures. Wherein:

FIG. 1 shows a cross-section of an autoinjector,

FIG. 2 shows an exploded view of the activator unit, and

FIGS. 3 to 6 show schematic cross-sectional views of an autoinjector.

According to FIG. 1, an autoinjector comprises an injection unit 9 atits distal end. Located inside said injection unit are a cartridge 11,which contains the drug, and the needle 12. The cartridge 11 is sealedat its distal end by a cartridge seal 16. At its proximal end, thecartridge 11 comprises a pressure pin 4, which can be moved into thecartridge. The needle 12 is held by a needle holder 13. The activatorunit is disposed at the proximal end of the autoinjector. It is screwedor otherwise connected to the injection unit 9, and is shown in itssecured state in FIG. 1, i.e. a first coil spring 1 and a second coilspring 2 are in the tensioned state between a piston 15 at the distalend and a locking mechanism at the proximal end. To maintain the lockedstate, a retaining element 5 holds the piston 15 in position by means ofdetent projections 6. Respective movement of the detent projections 6along the longitudinal axis of the activator unit is prevented by asafety cap 8 that comprises a central pin which restricts the freedom ofmovement of the detent projections 6. In addition, an activator sleeve 7is disposed around the circumference of the housing 3 of the activatorunit and can be moved towards the distal end of the activator unit andtowards the autoinjector as a whole. In the prior art, it was notpossible to accommodate both a first coil spring 1 and a second coilspring 2 in the activator unit. The reason was that the autoinjector asa whole and the activator unit must form a manageable instrument andtherefore space inside the activator unit is very limited. Sinceautoinjectors were previously based on conventional hypodermic syringes,a coil spring was disposed in the interior of the hollow piston rod orin the hollow space within the coil spring. Because the piston roditself takes up space, there was only enough room for one spring, andtherefore a natural ceiling was set for the pressure available to act onthe piston. Eliminating the piston rod was not previously consideredbecause this would have given the mechanical elements uncontrollabledegrees of freedom, especially in their sequence of movements. Accordingto the invention, however, the long piston rod is removed while at thesame time the space that this frees up is taken up by a second coilspring. The resulting surprising effect is that the springs guide eachother both in the tensioned locked state and during the injectionprocess, and movement is possible only in the direction of release, i.e.towards the distal end of the activator unit. In this way, the springforce acting on pressure pin 4 and piston 15 can be increasedsubstantially without substantial changes to the external dimensions ofthe activator unit.

FIG. 2 shows how the prior art piston, consisting of distal piston endand piston rod, is replaced by only the simple piston 15 shown in FIG.2. The retaining element 5 is inserted through the first coil spring 1and the second coil spring 2 and is latched into a proximal opening inthe housing 3. Both springs rest on the piston 15 via a spring adapter17. All that remains is for the activator sleeve 7 and the safety cap 8to then be placed on the housing 3. The activator unit, which can beproduced and stored separately from the injection unit 9, does not needto be sterile. The piston 15 does not apply pressure to the pressure pin4 of the injection unit 9 until the moment of injection; before that,the piston 15 is locked in place in the activator unit and the pressurepin 5 is seated inside the cartridge 11 in the sterile injection unit 9.To improve its compliance with sterility requirements the injection unit9 is sealed at its proximal end by a thin film of a suitable material.The seal remains intact even while the activator unit is connected tothe injection unit 9 because pressure pin 4 and piston 15 are spacedapart from each other. However, for smooth operation it is advantageousfor the piston 15 to have a mechanical means for breaking the seal. Thismeans can consist, for example, in the piston 15 comprising a ring orsome other geometric arrangement of teeth on its distal end face, whichteeth slit open the film-type seal at the beginning of the injectionprocess.

FIG. 3 shows an autoinjector having the activator unit according to theinvention and the injection unit 9 connected thereto in the initialposition. The cartridge 11 is sealed and is not yet connected to theneedle 12. The first coil spring 1 and the second coil spring 2 aretensioned and are locked by the retaining element 5, which is fixed bythe safety cap 8.

FIGS. 4, 5 and 6 illustrate the injection sequence by showing threestates of the autoinjector. In FIG. 4, the safety cap 8 has already beenremoved and the activator sleeve 7 has been moved in the distaldirection. At the same time, the distal end of the autoinjector isplaced on a body part of a patient, for example (not shown). Moving theactivator sleeve 7 has pressed the detent projections 6 of the retainingelement 5 toward one another, which releases the lock. The first coilspring 1 and the second coil spring 2 start to relax. This appliespressure to the piston 15, which starts moving into the distaldirection. The initial result is that it comes into contact with thepressure pin 4 and starts moving it as well. The injection unit 9 as awhole is now configured such that the pressure pin 4 does not movewithin the cartridge 11 but carries the cartridge 11 along with it andpresses it against the needle 12. The needle punctures the cartridgeseal 16 and in this way connects with the cartridge 11 itself.

Once the needle 12 and the cartridge 11 are fully connected, thepressure pin 4, the cartridge 11 along with the drug, and the needle 12are moved further in the distal direction by the spring pressure appliedby both the first coil spring 1 and the second coil spring 2. The needle12 punctures any seal on the distal end of the injection unit 9, andthen the needle 12 penetrates into the patient's body part. Since theneedle holder 13 and the cartridge 11 are then at their distal end pointand come to a stop inside the injection unit 9, the pressure that isstill being applied to the pressure pin 4 by the first coil spring 1 andthe second coil spring 2 via the piston 15 then causes the drug to beejected through the needle 12. In this last step, the high compressionforce of two springs acting in parallel is unleashed.

FIG. 6 shows the end position of the autoinjector comprising theinjection unit 9 and the activator unit according to the invention. Boththe first coil spring 1 and the second coil spring 2 have moved thepressure pin 4 to the distal end of the cartridge 11. The drug is nowcompletely ejected.

In the embodiment of the autoinjector comprising the activator unitaccording to the invention that is shown in the figures, the two springswork at the same time. It is likewise possible for telescopic sleevesknown from the prior art to be used to achieve a serial sequence ofmotions of the first coil spring 1 and the second coil spring 2. In suchan embodiment, the first coil spring 1 pushes the cartridge 11 and theneedle 12 as well as the second coil spring 2 in the distal direction.During this process, the second coil spring 2 is locked to an elementand held therein. This element can be a respective telescopic sleeve.The second coil spring 2 is unlocked shortly before or exactly when thecartridge 11 together with the needle 12 reach their maximum distalpoint. At that moment, the second coil spring 2 applies the force toeject the drug. It is an advantage of this embodiment that an increasedforce for ejecting the drug is again available. Conversely, it is alsopossible for the second coil spring 2 to be released first and to movethe first coil spring 1 in a locked state to the distal end, and for thefirst spring 1 to be released only when cartridge 11 and needle 12 havearrived at the distal end of the autoinjector or are a short distancebefore it.

Staggered unlocking is necessary particularly with highly viscous activeingredients, which means that an increased spring force is not so muchrequired at the beginning of the motion sequence of the autoinjector,when the cartridge 11 merely has to be connected to the needle 12 andthe needle 12 has to puncture the patient's body part, but at the end ofthe motion sequence, when what is left to do is to push the pressure pin4 through the cartridge 11.

Another advantage is that the recoil force which occurs when theactivator is released and which is perceived as uncomfortable bypatients using the device is much lower in the activator according tothe invention than in prior art activators.

Various modifications of the embodiments mentioned are conceivable. Forexample, the first coil spring 1 can be connected to the second coilspring 2 to form an integral double spring. This can prove advantageousin the manufacturing process of the coil spring itself and whenassembling the activator unit. The advantage of the increased forceresulting from the action of two coil springs on the piston 15 ismaintained in this embodiment. It is also conceivable for the activatorunit and the injection unit 9 to be configured not as separate and/orconnectable to one another via a screwed connection, but as connectableto one another by some other means or produced as a single piece fromthe start.

1. An activator unit for an autoinjector comprising a substantiallycylindrical housing (3) in which an axially movable pressure pin (4) isguided, said pressure pin being insertable counter to a spring unit andbeing lockable, when inserted, by means of detent projections (6) of aretaining element (5) that is connected to the pressure pin,characterized in that the spring unit comprises a first coil spring (1)and at least one second coil spring (2) having a larger diameter thanthe first coil spring (1), the second coil spring (2) being coaxial tothe first coil spring (1).
 2. The activator unit according to claim 1,characterized in that the first coil spring (1) and the second coilspring (2) have substantially the same length.
 3. The activator unitaccording to claim 1 or 2, characterized in that the first coil spring(1) and the second coil spring (2) are designed as parts of an integraldouble spring.
 4. The activator unit according to claim 1, characterizedin that the second coil spring (2) is retained and locked by an elementthat can be moved by the first coil spring (1), wherein the locking ofthe second coil spring (2) can be unlocked when the first coil spring(1) is at an outer release point.
 5. The activator unit according toclaim 1, characterized in that the first coil spring (1) is retained andlocked by an element that can be moved by the second coil spring (2),wherein the locking of the first coil spring (1) can be unlocked whenthe second coil spring (2) is at an outer release point.
 6. Theactivator unit according to any one of claims 1 to 5, characterized inthat the activator unit comprises an activator sleeve (7) that can bemoved in an axial direction, by which the detent projections (6) can bemoved such that the lock is unlocked and the pressure pin (4) can bemoved by the spring unit.
 7. The activator unit according to claim 6,characterized in that the activator unit comprises a removable safetycap (8) which includes an element that fixes the detent projections inplace.
 8. The activator unit according to any one of claims 1 to 7,characterized in that the activator unit comprises at its distal end athread or a bayonet lock by which it can be connected to an injectorunit (9).
 9. The activator unit according to claim 8, characterized inthat the pressure pin (4) comprises on its distal end face mechanicalmeans for breaking a seal.
 10. An autoinjector comprising an activatorunit according to claims 1 to 9.